Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name shoulder arthroplasty implantation system
510(k) Number K230904
Device Name Arthrex Virtual Implant Positioning (VIP) System
Applicant
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Troy Brooks
Correspondent
Arthrex Inc.
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Troy Brooks
Regulation Number888.3660
Classification Product Code
QHE  
Date Received03/31/2023
Decision Date 06/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-